My Experience

Founder & Owner

  • Clinical Evaluation Consulting
  • PMS/PMCF Consulting
  • Clinical Development Planing
  • Regulatory Affairs Consulting
  • Clinical Data generation

Freelance Consultant – Projects

  • Clinical Evaluation process for external service provider
  • Clinical Evaluation process for CRO
  • Regulatory Strategy and Clinical Evaluation according to MEDDEV 2.7.1 for a resorbable medical device
  • Regulatory Strategy for coated stent
  • Risk Management consultant for manufacturer of dialysis products (leading global harmonization of Risk Management process with interface to
  • Clinical Evaluation process)
  • Regulatory Strategy for pharmaceutical application device
  • Risk Management for HF surgical device
  • Interim Risk Manager and team lead (Disposables for heart-lung machines; Update of 35 risk management files; Implementation of Risk Management tool)
  • Clinical Evaluations according to MEDDEV 2.7.1 for orthopaedic implants
  • Biological Safety Evaluation according to DIN EN ISO 10993-1 for orthopaedic implants
  • Regulatory Strategy for surgical instruments for orthopeadic implants
  • Regulatory Strategy and complete Technical Documentation for CE mark for mobile organizational units

Head of Regulatory Affairs

  • Responsible for all CE-marked medical devices (non-active) of SFM
  • Responsible regulatory affairs contact person for OEM clients from medical device and pharmaceutical industry
  • Responsible for update of all technical documentations
  • Process optimization for risk management
  • Implementation of clinical evaluation and usability engineering processes, as well as standardized procedures for preclinical testing
  • In-house training of colleagues in regulatory affairs topics
  • Strongly involved in implementation of document management system for the whole company
  • Demarcation between drugs and medical devices – Presentation at University of Applied Sciences in Ansbach, Germany
  • RAPS Online University student in dual course for pharmaceuticals, medical devices & combination products (US and EU regulations)
  • Speaker at conferences and seminars on Regulatory & Clinical Affairs (e.g. Forum Institut, BVMed)
  • Speaker at Medica/Compamed 2013 on Safety Protection Devices
  • Member of BVMed working team Regulatory and Political Affairs
  • Member of DIN working groups for quality management and risk management standard

Functional Head Non-active medical devices and Clinical Affairs

  • Responsible Manager for Clinical and Preclinical Affairs with a team of three employees and more than 15 freelance partners
  • Responsible for Clinical Evaluations according to MEDDEV 2.7.1 (Rev.3) for more than 100 different products of more than 50 different manufacturers
  • Clinical Evaluation and Drug Delivery Devices – In-house training and training in cooperation with Forum Institut and APV
  • Planning of Clinical Investigations according to EN ISO 14155 in cooperation with freelance partners
  • Biological Evaluations according to DIN EN ISO 10993-1 and coordination of tests with external labs
  • Technical Documentation, responsible for compilation of 20 technical files for joint implants (higher classification)
  • Expert statements concerning demarcation questions for medical devices and medicinal products
  • Summary Technical Documentation according to GHTF guidance
  • Review of 510(k) for active medical device
  • Support for reimbursement questions in Germany (G-BA and Hilfsmittelverzeichnis)
  • ISO 13485 Training, including QMB, internal auditor and third party auditor
  • Responsible for sales and acquisition for clinical evaluations and related topics
  • Strongly involved in business development of Yes Medical and interface to Yes Pharmaceutical Development Services (mother company)
  • Partly responsible for content of company website www.yes-services.eu and for online marketing of the site
  • Technical Documentation, compilation of 35 technical files for class I, IIa and IIb medical devices
  • Risk Analysis, Risk Management, DIN EN ISO 14971
  • Project management and coordination of a project including 15 team members and including communication with external partners on behalf of the client

Development Engineer

  • Product development: remittance work and in-house development
  • Patent and literature research, preliminary tests and conceptional development, product design and prototyping, support until serial production
  • Product example: Drug transfer systems (e.g.: EasyVial: easyvial.com), PEEK Cage, Liquor-Drainage System, Port-catheter system including port needle, Vertebroplasty syringe, Retractor system for minimal invasive surgery
  • Risk analysis and risk assessment, quality management for medical device manufacturer according to DIN EN ISO 13485
  • Clinical Evaluation including literature search and assessment of publications according to evidence based medicine

My Career

2002

Degree - University of Applied Sciences

2003

Development Engineer

2007

Functional Head

2012

Head of Regulatory Affairs

2014

Freelance Regulatory Affairs Expert

2018

Founder & Owner

My Skills

Clinical Evaluation

Technical File

Risk Management

Regulatory Strategy

Quality Management

Biocompatibility

Usability

My Values

compliant Clinical Evaluation Reports
MDR Implementation & Readiness
efficient Risk Management
optimized Requlatory Strategy
proactive Post-Market Surveillance
living Quality Management

My Availability

Clinical Evaluation Reports, process implementation & training

upon request

MDR Implementation projects

January 2018

All other projects

upon request

Florian Tolkmitt, Ostendstr. 54, 60314 Frankfurt am Main